FDA.reportPublic FDA data

Baxter

Primary DI
00815634021488
Brand
Baxter
Company
Micromedics, Inc.
Model
0600225
Device description
Endoscopic Applicator, 41 cm
Published
2025-06-18
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
GCJLaparoscope, General & Plastic Surgery

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GCJLaparoscope, General & Plastic SurgeryGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10815634021485PackageGS16In Commercial Distribution
20815634021482PackageGS11In Commercial Distribution
00815634021488PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081563402148510815634021485
2081563402148220815634021482
00815634021488008156340214888156340214880815634021488

GMDN Terms#

Term, Definition table
TermDefinition
Fibrin sealant biochemical preparation/application kit, endoscopicA collection of sterile devices designed to be used for the biochemical preparation and subsequent delivery of autologous fibrin sealant to a site of intervention during an endoscopic surgical procedure (e.g., to achieve haemostasis, seal air leaks, adhere tissues). It typically consists of a dedicated preparation unit (a cassette) with a collection of application devices including an endoscopic applicator, needle, and tubing. Patient blood is contained within the preparation unit which is placed in a production unit (processor) which controls the biochemical processes and centrifugation to produce the fibrin sealant. This is a single-use device.

Regulatory Flags#

DUNS number
066839630
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00815634020009MITEK SPORTS MEDICINE2780112019-01-16
00815634020016MITEK SPORTS MEDICINE2780122019-01-16
00815634020030MITEK SPORTS MEDICINE2780142019-01-16
00815634020047MITEK SPORTS MEDICINE2780152019-01-16
00815634020061FIBRIJETSA-36622016-09-25
00815634020078FIBRIJETSA-36542016-09-25
00815634020108DUPLOTIP06000372016-09-25
00815634020160FIBRIJETSA-36642016-09-25
00815634020245FIBRIJETSA-36512016-09-25
00815634020290NAAMS6122016-09-25
00815634020320FibriJetSA-61112016-09-25
00815634020337Arthrex BioExpressABS-10053-102021-04-25
00815634020450OSTEOPRECISIONGD-1215-1502017-01-13
00815634020467OSTEOXPRESSGD-55152017-01-13
00815634020474DUPLOSPRAY06000292017-01-13
00815634020481DUPLOSPRAY06000302017-01-13
00815634020498DUPLOSPRAY06000332017-01-13
00815634020504FIBRIJETSA-37682017-01-13
00815634020511Duplotip06011362018-06-15
00815634020528DuplotipSA3740030044442018-06-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B382SD1184590Surgical DirectSurgical Direct, Inc.GCJ2026-07-14
B382SD12711090Surgical DirectSurgical Direct, Inc.GCJ2026-07-14
B382SD1271390Surgical DirectSurgical Direct, Inc.GCJ2026-07-14
B382SD1271590Surgical DirectSurgical Direct, Inc.GCJ2026-07-14
B382SD13018770Surgical DirectSurgical Direct, Inc.GCJ2026-07-14
B382SD13168350Surgical DirectSurgical Direct, Inc.GCJ2026-07-14
B382SD23373490Surgical DirectSurgical Direct, Inc.GCJ2026-07-14
B382SD770561050Surgical DirectSurgical Direct, Inc.GCJ2026-07-14
B382SD775011530Surgical DirectSurgical Direct, Inc.GCJ2026-07-14
B382SD775021630Surgical DirectSurgical Direct, Inc.GCJ2026-07-14
B382SD77505650Surgical DirectSurgical Direct, Inc.GCJ2026-07-14
B382SD7751586C0Surgical DirectSurgical Direct, Inc.GCJ2026-07-14
B382SD7751587C0Surgical DirectSurgical Direct, Inc.GCJ2026-07-14
00850045863012ArthroFree® 2 ReceiverLazurite Holdings LLCGCJ2026-07-10
00850045863029ArthroFree® 2 Wireless Camera HeadLazurite Holdings LLCGCJ2026-07-10
00850045863036ArthroFree® 2 Operating Room KitLazurite Holdings LLCGCJ2026-07-10
00850045863043ArthroFree® 2 Single Camera Head SetLazurite Holdings LLCGCJ2026-07-10
B382SD883110450Surgical DirectSurgical Direct, Inc.GCJ2026-07-10
B382SD88324450Surgical DirectSurgical Direct, Inc.GCJ2026-07-10
00190776421731MillenniumAvalign Technologies, Inc.GCJ2026-06-24
00190776421663MillenniumAvalign Technologies, Inc.GCJ2026-06-23
00190776421687MillenniumAvalign Technologies, Inc.GCJ2026-06-23
00198506091506ELMED INCORPORATEDELMED INCORPORATEDGCJ2026-06-10
00198506044366ELMEDELMED INCORPORATEDGCJ2026-06-09
00812231033906PixaSANTA BARBARA IMAGING SYSTEMS, INC.GCJ2026-06-08
00812231033913PixaSANTA BARBARA IMAGING SYSTEMS, INC.GCJ2026-06-08
00812231033920PixaSANTA BARBARA IMAGING SYSTEMS, INC.GCJ2026-06-08
00812231034095PixaSANTA BARBARA IMAGING SYSTEMS, INC.GCJ2026-06-08
00812231034101PixaSANTA BARBARA IMAGING SYSTEMS, INC.GCJ2026-06-08
04717480900336Inno-PortTAIWAN SURGICAL CORPORATIONGCJ2026-06-08